Pathology Tissue Diagnosis Assistant Software II
๋ณ๋ฆฌ์กฐ์ง์ง๋จ๋ณด์กฐ์ํํธ์จ์ดII
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In Vitro Procedure No. 23-136. Approved on Apr 03, 2023. Registered by Roche Diagnostics Korea.
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2022004707
License Number
In Vitro Procedure No. 23-136
์ฒด์ธ์ํ23-136ํธ
Classification Number
P04010.01
Device Class (Risk Classification)
Unknown
Classification Name
Pathology Tissue Diagnosis Assistant Software II
๋ณ๋ฆฌ์กฐ์ง์ง๋จ๋ณด์กฐ์ํํธ์จ์ดII
Official English Name
Computer aided diagnosis software for pathological cells or tissue
Company Information
Category
In vitro diagnostic import business
์ฒด์ธ์ง๋จ์์
์
Business License Number
์ฒด์ธ ์ 730 ํธ
Important Dates & Status
Item Approval Date
Apr 03, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-04-03 ~ 2028-04-02
Model Information
Model Name
uPath HER2 Dual ISH image analysis for Breast Algorithm
